Ideas & Trends; Searching for the Quick Fix

By GINA KOLATA

Published: April 2, 1995

IN medicine, particularly at the fuzzy boundaries where medical science meets the unknown, the knife has long been the patients' therapy of choice.

Back in the mid-1970's, a rigorous test began on coronary bypass surgery. The study, established by the National Heart, Lung and Blood Institute, was to compare drugs with surgery, evaluating whether patients lived longer or felt better after the expensive operation.

But a problem rose immediately because many doctors -- and patients -- were already convinced that the operation was better than drugs for relieving chest pain. Researchers had trouble finding enough people to agree to have their treatment randomly assigned. Even when they did agree, many who were assigned to take drugs dropped out to have the operation anyway. The resulting data were difficult to interpret and subject to dispute, said Dr. Julie Swain, chief of cardiovascular surgery at the University of Nevada School of Medicine.

Why does surgery have an allure that a pill cannot match? Why do unproven surgical procedures so entrance people who would scoff at being part of a trial of an experimental drug? The reasons are unclear, but it is clear that the cachet attaches to not only effective operations but also untested procedures that may kill patients or leave them worse off.

Dr. William Weiner, a neurologist who directs the movement disorders clinic at the University of Miami School of Medicine, says that when many patients learn of a new surgery for Parkinson's disease, they point to their heads and say, "Put the hole here." But if he asks them to participate in a drug study, he said, "they may say they don't want to be a guinea pig."

"They have this concept that surgery is going to cure everything," Dr. Weiner said. "It's like an appendectomy and you're all better. That's just not the case for neurological diseases."

'Like Lemmings'

Patients, facing a diagnosis of cancer, heart failure or other debilitating disease, seek surgery out of desperation. Dr. John Paris, an ethicist at Boston College, said patients often "rush in like lemmings" when offered surgery.

Many critics fault surgeons for Americans' overly optimistic expectations of what operations can do. But Dr. Swain argues that doctors often must test new techniques on dying patients who have no other options.

Some patients also hear what they want to hear.

Two years ago, Sylvia Sellarole, a 60-year-old Parkinson's disease patient in Redland, Calif., was desperate to have a pallidotomy, the highly experimental brain surgery that destroys nerves thought to be overactive in the disease. At the time, she said she thought her surgeon, Dr. Robert Iacono of Loma Linda University Medical Center, "walked on water."

Now Ms. Sellarole says she is worse off than before. Yet despite the absence of reliable data on the safety and effectiveness of a pallidotomy, Parkinson's patients are begging surgeons for it.

Dr. Swain said that although academic surgeons cannot do the controlled double-blind trials so common to drug research, they do try to assess experimental operations. In double-blind drug trials, some patients get placebos and others active drugs; neither the patient nor the doctor administering the pills knows which patient is getting what.

"The problem comes when people start to do an operation and there's a hint that it actually works," Dr. Swain said. "Then you can't justify having an untreated group."

When the National Cancer Institute sponsored a study in 1976 comparing mastectomy with the less drastic but less studied lumpectomy, it took eight years to find enough participants. Women did just as well with lumpectomies.

Now the institute is trying to find men with early-stage prostate cancer who will agree to be randomly assigned to surgery or "watchful waiting." Although the standard treatment for early prostate cancer is to remove the gland, no one has shown that the operation improves the chances of long-term survival. The operation usually results in impotence or incontinence. But, said Dr. Larry Kessler, chief of the applied research branch at the cancer institute, "it is very difficult getting this trial going," because few men are willing to forgo surgery.

Unlike surgery, new drugs require rigorous evaluation. The Food and Drug Administration bars companies from giving experimental drugs to people outside of scientific studies and strictly limits their distribution during the trial process. Although dying patients have also flocked to useless drugs, including laetrile and other ostensible treatments for cancer, the drugs on the market have all been were scientifically evaluated and shown to work.

Back to Earth

"We put the responsibility on the drug company," said George Annas, an ethicist and health law professor at Boston University.

In contrast, surgery appears more immediate. "We've never been able to control surgeons," he said. "They don't do randomized controlled clinical trials -- they give surgery to everybody and they report the success of their theories."

Dr. Swain said such criticisms are unjust. Desperate patients seeking a surgical or a drug miracle, she said, "have to depend on people who are honest and rigorous" to bring them back to earth.

Photo: Sylvia Sellarole, above, worsened after brain surgery. (Michael Tweed for The New York Times)